COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/1125 
of 5 June 2019 
concer ning the author isation of zinc chelate of methionine sulfate as a feed additiv e for all animal 
species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provi des for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitte d for the author is­
ation of zinc chelate of methionine sulfate. That application was accompanied by the particulars and documents 
required under Article 7(3) of that Regulation. 
(3)  That application concer ns the author isation of zinc chelate of methionine sulfa te as a feed additive for all animal 
species to be classified in the additive categor y ‘nutr itional additives’. 
(4)  The European Food Safety Authority (‘the Author ity’) concluded in its opinions of 18 May 2017 (2) and 
4 Octobe r 2018 (3) that, under the proposed conditions of use, zinc chelate of methionine sulfat e does not have 
an adverse effect on animal health and consumer safety . It also concluded that the additive is considered as 
a poten tial skin sensitizer and an eye and skin irritant and stated a risk for the users of the additive upon 
inhalation. Theref ore, the Commission considers that appropr iate protective measures should be take n to prevent 
adverse effects on human health, in particular as regards the users of the additive. The Auth ority also concluded 
that that additive does not pose an additional risk for the environment compar ed to other compo unds of zinc 
and that it is an effic acious source of zinc for all animal species. The Authority does not consider that there is 
a need for specif ic requirements of post-market monitoring. It also verified the repor t on the method of analysis 
of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. 
(5)  The assessment of that additive shows that the conditions for author isation, as provid ed for in Article 5 of 
Regulation (EC) No 1831/2003, are, subject to respective protective measures for the users of the additive, 
satisfied. According ly, the use of that additive should be author ised as specifi ed in the Annex to this Regulation. 
(6)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The substance specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional 
group ‘compounds of trace elements’, is author ised as an additive in animal nutr ition subject to the conditions laid 
down in that Annex. 2.7.2019 L 177/77 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Journal 2017;15(6):4859. 
(3)EFSA Journal 2018;16(10):5463. Article 2 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 5 June 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  2.7.2019 L 177/78 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author is­
ation Additive Composition, chem ical formula, 
descr iption, analytical method Species or 
category of 
animal Maxim ­
um age Minimum 
content Maximum conten t 
Other provisions End of 
period of 
author is­
ation Conten t of element (Zn) in mg/kg of 
complet e feed with a moisture 
content of 12 % 
Categor y of nutr itional additiv es. Functional group: compounds of trace elements 
3b614 — Zinc chelat e 
of methionine 
sulfate Additiv e composition: 
Zinc chelate of methionine sulfa te 
as a powder with a zinc cont ent 
between 2 % and 15 %. 
Char acter isation of the activ e sub­
stance: 
Zinc, 2-amino-4 meth ylsulfan yl­
butanoic acid, sulfa te; zinc che­
lated with methionine in a molar 
ratio 1:1. 
Chemical formula: C5H11NO6S2Zn 
CAS Number: 56329-42-1 
Analytical methods (1): 
For the quantifi cation of total zinc 
in the feed additive and premix ­
tures: 
— EN 15510: Inductively 
Coupled Plasma – Atomic 
Emission Spectrometr y (ICP - 
AES), or 
— EN 15621: Inductively 
Coupled Plasma – Atomic 
Emission Spectrometr y (ICP - 
AES) after pressure dige stion.  All animal 
species — — Dogs and cats: 200 
(total) Salmonids 
and milk replacers 
for calves: 180 
(total) 
Piglets, sows, rabbits 
and all fish other 
than salmonids: 150 
(total) 
Other species and 
catego ries: 120 
(total)  1.The additive shall be incor ­
porat ed into feed in the form 
of a premixture. 
2.  Zinc chelate of methionine 
sulfate may be placed on the 
mark et and used as an addi ­
tive consisting of a prepara ­
tion. 
3.  For users of the additive and 
premixtures, feed business 
operat ors shall establish op­
erational procedures and 
appropr iate organisational 
measures to address the po­
tential risks by inhalation, 
dermal contact or eyes 
contact. Where risks cannot 
be reduced to an acceptab le 
level by those procedures and 
measures, the additive and 
premixtures shall be used 
with appropr iate personal 
prot ective equipment.  22 July 
2029 2.7.2019 L 177/79 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author is­
ation Additive Composition, chem ical formula, 
descr iption, analytical method Species or 
category of 
animal Maxim ­
um age Minimum 
content Maximum conten t 
Other provisions End of 
period of 
author is­
ation Conten t of element (Zn) in mg/kg of 
complet e feed with a moisture 
content of 12 % 
For the quantifi cation of methio ­
nine conte nt in the feed additive: 
— ion exchange chromat ography 
coupled with post-column de­
rivatisation and phot ometr ic 
detection (IEC-UV/FD) – EN 
ISO 17180 or VDL UFA 4.11.6 
and EN ISO 13903 
For the quantifi cation of total zinc 
in feed mater ials and compo und 
feed: 
— Regulation (EC) No 152/2009 
— Atomic Absor ption Spec ­
trometr y (AAS); or 
— EN 15510: Inductively 
Coupled Plasma – Atomic 
Emission Spectrometr y (ICP - 
AES); or 
— EN 15621: Inductively 
Coupled Plasma – Atomic 
Emission Spectrometr y (ICP - 
AES) after pressure dige stion. 
(1)  Details of the analytical methods are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/eurl/feed-additiv es/evaluation-repor ts   2.7.2019 L 177/80 Official Jour nal of the European Union EN